Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)

Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02633904

Acronym

FSODDH

Enrollment

200

Registered

2015-12-17

Start date

2015-12-31

Completion date

2020-12-31

Last updated

2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Head Necrosis, Hip Dislocation

Keywords

Hip Dislocation, Congenital, osteotomy, Femur Head Necrosis

Brief summary

Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy.

Detailed description

Developmental dislocation of the hip (DDH) is a common disease in children, and its incidence in China is about 9 ‰.There are many different methods in the treatment of DDH. Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy. From the investigators'clinical experiences and the published papers, younger patients (\<24 month of age) and low dislocations (Tonnis level I or II) were more likely to avoid a femoral shortening osteotomy.

Interventions

PROCEDUREOsteotomy

Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

PROCEDURENon-osteotomy

Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Months to 24 Months

Healthy volunteers

Inclusion criteria

1. Unilateral DDH,age 18-24month. 2. Tonnis degree I or II. 3. Not receive any open treatment.

Exclusion criteria

1. Teratologic hip dislocations, 2. Patients with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth, cerebral palsy, multiple joint contractures disease, dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities. 3. Any children with prior hip surgery were excluded from the series. 4. Parents refused further treatment.

Design outcomes

Primary

Measure	Time frame	Description
Femur Head Necrosis	2 years	Radiological evaluation was performed using standard anterior-posterior radiographs of the pelvis. The presence and grade of femur head necrosis was evaluated according to the method presented by Bucholz and Odgen.
Redislocation	2 years	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Acetabular index	2 years	Standardized radiographs have been traditionally used in the surveillance of hip dysplasia by measuring the acetabular index, which is the angle subtended between the Hilgenreiner line and a line drawn from the triradiate cartilage to the lateral edge of the acetabulum.

Secondary

Measure	Time frame	Description
Duration of operation	1 month	The time during the operation measured by minute.
Hospital stays	1 month	The days stayed in hospital.
Blood loss	1 month	The blood lost during the operation measured by milliliter.
Cost	1 month	The cost of hospitalization.

Contacts

Primary ContactPeng J He, Doctor

619921411@qq.com+86-15071032254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026